HPV is the most common sexually
transmitted infection in the United States. Currently, more than 20
million men and women in
the United States are infected with HPV, and more than 6 million are
estimated to become infected each year. HPV is most
common in young women and men in their late teens and early 20s. By
age 50, at least 80 percent of sexually active women will
have acquired HPV infection.

How serious is disease caused by
HPV?

HPV infection can lead to cervical
cancer in women as well as to other anogenital cancers that can affect
males or females.
Cervical cancer is diagnosed in more than 12,000 women each year in
the United States each year and causes 4,200 deaths.
Seventy percent of cervical cancers are caused by HPV types 16 and 18,
which are included in both licensed HPV vaccines. HPV types 6 and 11
also cause over 90% of genital warts in men and women.

Can human papillomavirus (HPV) be
transmitted by non-sexual transmission routes,
such as clothing, undergarments, sex toys, or
surfaces?

Nonsexual HPV transmission is
theoretically possible but has not been
definitely demonstrated. This is mainly
because HPV can't be cultured and DNA
detection from the environment is difficult
and likely prone to false negative results.

Please provide more information
about the two HPV vaccines, Cervarix (GSK) and Gardasil (Merck). What
are the differences
between them?

Cervarix is an inactivated bivalent
vaccine (HPV2) that protects against HPV types 16 and 18. Gardasil is
an inactivated
quadrivalent vaccine (HPV4) that protects against HPV types 16 and 18,
and also against types 6 and 11, which are human
papillomaviruses that cause genital warts.

What are the CDC recommendations
for use of HPV vaccine?

ACIP recommends that all males and
females ages 11 through 12 years be routinely vaccinated with a 3-dose
series; either HPV2
(Cervarix) or HPV4 (Gardasil) may be used in females, and only HPV4 (Gardasil)
should be used in males. HPV vaccination is
also recommended for females through age 26 years and males through
age 21 years who have not completed or begun a 3-dose
series. In addition, vaccination is recommended for men age 22 through age 26 years who 1) have sex with men or 2) are
immunocompromised as a result of infection (including HIV), disease,
or medication. Ideally, HPV vaccine should be
administered before potential exposure to HPV through sexual contact.
The vaccination series can be beginning as young as age
9 years at the clinician's discretion.

Both HPV vaccines should
be given as a 3-dose schedule, with the second dose
given 1 to 2 months after the first dose and the
third dose 6 months after the first dose. The minimum
interval between the first and second doses of vaccine
is 4 weeks. The
minimum interval between the second and third doses of vaccine is 12 weeks. The minimum interval between the
first and third
doses is 24 weeks. Whenever possible, use the same brand
of HPV vaccine for all doses in the series given to
females. In
situations when that's not possible, use the second HPV
brand to complete the series. It is not necessary to
start the series
over. For more information, see the ACIP recommendations
from CDC at www.cdc.gov/vaccines/pubs/acip-list.htm.

Please describe the new
recommendations for the use of HPV4 vaccine in males and explain how
these new recommendations differ
from the previous ones.

ACIP recommends routine vaccination of
males age 1112 years with HPV4 (Gardasil, Merck) administered as a
3-dose series. The vaccination series can be started beginning at age
9 years. Vaccination with HPV4 is recommended for males age 13 through
21 years who have not been vaccinated previously or who have not
completed the 3-dose series. Males age 22 through 26 years may be
vaccinated with HPV4.

ACIP recommends that
immunocompromised males who have not been vaccinated
previously or who have not completed the 3-dose
series receive routine vaccination with HPV4 through age
26 years.

Men who have sex with men
(MSM) are at higher risk for infection with HPV types 6,
11, 16, and 18 and associated conditions,
including genital warts and anal cancer. ACIP recommends
that MSM who have not been vaccinated previously or who
have not
completed the 3-dose series receive routine vaccination with HPV4 through age 26 years. Previously, ACIP had
issued
permissive recommendations for HPV4 use in males age
926 years for the prevention of genital warts.

My office recently changed HPV vaccine brands from Gardasil to Cervarix. We have several males who received doses of Cervarix instead of Gardasil. Do the males who received Cervarix need to be revaccinated?

Yes. Cervarix (HPV2, GlaxoSmithKline) is not approved or recommended for use in males. Doses of HPV2 administered to males should not be counted and need to be repeated using Gardasil (HPV4, Merck).

Is use of HPV vaccine covered under
the Vaccines For Children (VFC) program?

Yes. VFC-eligible females, ages 9
through 18 years, can be given either HPV2 (Cervarix) or HPV4 (Gardasil);
VFC-eligible
males, ages 9 through 18 years, should be given HPV4 (Gardasil).

Are pap smears still necessary for
women who receive HPV vaccine?

Yes. Vaccinated women still need to
see their healthcare provider for periodic cervical cancer screening.
The vaccine does
not provide protection against all types of HPV that cause cervical
cancer, so even vaccinated women will still be at risk
for some cancers from HPV.

Do women and men whose sexual
orientation is same-sex need HPV vaccine?

Yes. HPV vaccine is recommended for
females and males regardless of their sexual orientation.

Will patients who have already had
genital warts benefit from receiving Gardasil?

A history of genital warts or
clinically evident genital warts indicates infection with HPV, most
often type 6 or 11.
However, people with this history might not have been infected with
both HPV 6 and 11 or with HPV 16 or 18. Vaccination will
provide protection against infection with HPV vaccine types the
patient has not already acquired. Gardasil (HPV4) protects
against HPV vaccine types 6, 11, 16, and 18; Cervarix (HPV2;
GlaxoSmithKline) protects against HPV 16 and 18. Providers
should advise their patients/clients that results from clinical trials
do not indicate the vaccine will have any therapeutic
effect on existing HPV infection or genital warts. It is important,
however, that patients receive all 3 doses of HPV4
vaccine to get full protection from genital warts.

If a patient has been sexually
active for a number of years, is it still recommended to give HPV
vaccine or to complete the
HPV vaccine series?

Yes. You should not withhold HPV
vaccine from people who are already sexually active. Ideally, patients
should be vaccinated
before onset of sexual activity; however, patients who have already
been infected with one or more HPV types still get
protection from other HPV types in the vaccine that have not been acquired.

I read that HPV vaccination rates are still low. What can we do as providers to improve these rates?

Results from the Centers for Disease Control and Prevention's 2012 National Immunization Survey-Teen (NIS-Teen) indicate that HPV vaccination rates in girls age 13 through 17 years failed to increase between 2011 and 2012, and the 3-dose coverage rate actually declined slightly during this period. Just over half of the girls age 13 through 17 years had started the series that they should have completed by age 13 years. Only about one-third of girls this age had completed the series. In 2012, the first year HPV vaccine was routinely recommended for boys, 20.8% of boys age 13 through 17 years had received one dose and only 6.8% had received all three recommended doses. A summary of the 2012 NIS-Teen survey is available at www.cdc.gov/mmwr/pdf/wk/mm6234.pdf, page 685.

Providers can improve uptake of this life-saving vaccine in two main ways. First, studies have shown that missed opportunities are a big problem. Eighty-four percent of girls unvaccinated for HPV had a healthcare visit where they received another vaccine such as Tdap, but not HPV. If HPV vaccine had been administered at the same visit, vaccination coverage for one or more doses could be nearly 93% instead of 54%. Second, the 2012 NIS-Teen data show that not receiving a healthcare provider's recommendation for HPV vaccine was one of the five main reasons parents reported for not vaccinating daughters.

CDC urges healthcare providers to increase the consistency and strength of how they recommend HPV vaccine, especially when patients are age 11 or 12 years. The following resources can help providers with these conversations.

Both HPV vaccines should be
administered in a 3-dose schedule, with the second dose administered 1
to 2 months after the
first dose and the third dose 6 months after the first dose. The
minimum interval between the first and second doses of
vaccine is 4 weeks. The minimum interval between the second and third
doses of vaccine is 12 weeks. The minimum interval
between the first and third doses is 24 weeks.

If a dose of HPV vaccine is
significantly delayed, do I need to start the series over?

No, do not restart the series. Just
pick up where the patient left off and complete the series.

To accelerate completion of the
human papillomavirus (HPV) vaccine series, can doses be given at 0, 1,
and 4 months?

No, there is no accelerated schedule
for completing the HPV vaccine series. You should follow the
recommended schedule of 0,
1-2, and 6 months.

What are the minimum intervals between doses of HPV vaccine?

Minimum intervals are used when patients have fallen behind on their immunization schedule or when they need their dosing schedule expedited (for example if there is imminent travel). The minimum interval between the first and second doses of HPV vaccine (either HPV4 or HPV2) is 4 weeks. The minimum interval between the second and third dose is 12 weeks. ACIP recommends an interval of 24 weeks between the first and third dose. However, the third dose can be considered to be valid if it was separated from the first dose by at least 16 weeks and from the second dose by at least 12 weeks.

I work with university students and
many of them miss coming in on time for their next dose of HPV
vaccine. What's the
longest interval allowed before we need to start the series over?

No vaccine series needs to be
restarted because of an interval that is longer than recommended (with
the exception of oral
typhoid vaccine in certain circumstances). You should continue the
series where it was interrupted. If the HPV series is
begun when the university student is age 26 or younger, it can be
completed after the student turns 27. It's important to
rely on the actual recommendations, not urban legends or guesswork.
All ACIP recommendations can be accessed at www.immunize.org/acip. ACIP's "General Recommendations on
Immunization" are especially useful: www.cdc.gov/mmwr/PDF/rr/rr5515.pdf

Is it recommended that patients age
26 years start the HPV vaccination series even though they will be
older than 26 when
they complete it?

Yes. HPV vaccine is recommended for
all women through age 26 years and also may be given to men through
that age. So, the 3-dose series can be started at age 26 even if it will not be completed
at age 26. The series should be completed regardless of
the age of the patient (i.e., even if the patient is older than 26).
In certain situations, some clinicians choose to start
the 3-dose HPV series in patients who are older than 26 years. This,
however, is an off-label use.

We inadvertently gave HPV #1 to a
woman who didn't know she was pregnant at the time. How should we
complete the schedule?

If the vaccine was Cervarix the
vaccination incident should be reported to the GlaxoSmithKline
registry (888-452-9622). Merck no longer maintains a registry for
Gardasil (see next question). You should withhold
further HPV vaccine until she is no longer pregnant.
Shortly after the pregnancy is completed, administer HPV#2 assuming
1-2 months have passed since HPV#1. Give HPV#3 6 months
after HPV#1, but no earlier than 12 weeks after HPV#2.

Why did Merck discontinue the
registry for collecting reports of pregnant women who inadvertently
received its HPV vaccine (Gardasil) during pregnancy?

Because HPV vaccine is not recommended
for use during pregnancy, Merck facilitated a registry to document
outcomes when its HPV vaccine (Gardasil) was inadvertently
administered to pregnant women. This registry was ongoing for more
than 6 years (June 2006 through April 2013), and Merck has fulfilled
its FDA obligation to facilitate it. The data from the registry are
reassuring with respect to safety after pregnancy exposures. Review of
the data collected during the first 5 years of the registry does not
support a causal relationship between HPV vaccine and birth defects.

Can HPV vaccine be administered at
the same time as other vaccines?

Yes, coadministration of a different
inactivated or live vaccine, either simultaneously or at any time
before or after HPV
vaccine, is permitted because neither HPV vaccine is a live vaccine.

If HPV vaccine is given
subcutaneously (SC) instead of intramuscularly (IM), does the dose
need to be repeated?

Yes. No data exist on the efficacy or
safety of HPV vaccine given by the subcutaneous route. All data on
efficacy and
duration of protection are based on a 3-dose series given on the
approved schedule and administered by the intramuscular
route. In the absence of data on subcutaneous administration, CDC and
the manufacturers recommend that a dose of HPV vaccine
given by any route other than intramuscular should be repeated. There
is no minimum interval between the invalid
(subcutaneous) dose and the repeat dose.

If a 30-year-old female patient
insists that she wants to be given HPV vaccine, can I give it to her?

HPV vaccine is not FDA-licensed for
use in women older than age 26 years at this time. Studies are
currently being conducted
in women age 27 years and older. ACIP does not recommend the use of
this vaccine outside the FDA licensing guidelines;
however, many physicians administer this vaccine as off-label use.
There is no reason to believe the vaccine would be any
less safe for women in this age group than for younger women.
Clinicians should decide if the benefit of the vaccine
outweighs the hypothetical risk.

Yes. Women who have evidence
of present or past HPV infection and who are younger than age 27 years
should be vaccinated.
They should be advised that the vaccine will not have a therapeutic
effect on existing HPV infection or any cervical lesions.

Can a woman who is breastfeeding
receive HPV vaccine?

Yes.

Is the history of an abnormal pap a
contraindication to the HPV vaccine series?

No. Even a woman found to be infected
with a strain of HPV that is present in the vaccine could receive
protection from the
other 3 strains in the vaccine.

We've heard stories in the media
lately about severe reactions to the HPV vaccine. Is there any
substance to these stories?

No. In summer 2008 some
concerns were raised over two issues  reports of deaths and reports
of Guillain-Barrè syndrome (GBS)
following vaccination with Gardasil. As of September 2011, the
manufacturer of Gardasil (Merck) reported it had distributed
more than 40 million doses of Gardasil in the United States. At that
time, the federal Vaccine Adverse Events Reporting
System (VAERS) had received reports of 71 deaths, although only 34
could be confirmed. Among these 34 deaths, CDC reported
that there was not a common pattern to the deaths; if there had been a
common pattern, it would suggest the deaths might be
caused by the vaccine.

Occurrences of GBS, a rare neurological disorder, have been reported
through VAERS. FDA and CDC reviewed the reports and
found no evidence that Gardasil increased the rate of
GBS above what is expected in the population. CDC,
working with the FDA
and other immunization partners, will continue to monitor the safety of Gardasil and Cervarix vaccines.
You can find complete
information on this and other vaccine safety issues at www.cdc.gov/vaccinesafety/vaccines/HPV/gardasil.html.

This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.